Visual Performance of Senofilcon A With and Without a New UV/HEV-filter
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- Mesopic Contrast Sensitivity at 6 Cpd
研究概览
简要总结
This study will occur in two non-dispensing phases: Phase 1 is a non-randomized, non-masked, non-dispensing study where subjects will wear their own contact lenses for approximately 1 hour. Phase 2 is a controlled, randomized, double-masked, contralateral non-dispensing study where the study lenses will be worn in a daily wear modality for approximately 3 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Potential subjects must satisfy all of the following criteria to be enrolled in the study:
- •Read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
- •Appear able and willing to adhere to the instructions set forth in this clinical protocol.
- •For Phase I be between 18-39 (inclusive) years of age at the time of screening.
- •For Phase II be between 18 and 70 (inclusive) years of age at the time of screening.
- •By self-report, habitually wear spherical silicone hydrogel soft contact lenses in both eyes in a daily reusable or daily disposable wear modality (i.e. not extended wear modality). Habitual wear is defined as a minimum of 6 hours of wear per day, for a minimum of 5 days per week during the past 30 days.
- •Possess a wearable pair of spectacles that provide correction for distance vision.
- •Habitual spherical contact lens powers must be between -1.00 D and -6.00 D (inclusive) in each eye.
- •For Phase I, habitual contact lenses must provide at least 20/20 acuity OD and OS.
- •For Phase II, the spherical equivalent of the subject's vertex-corrected distance refraction must be between -1.00 D and -6.00 D (inclusive) in each eye.
- •For Phase II, the magnitude of the cylindrical component of the subject's vertex-corrected distance refraction must be between 0.00 D and 1.00 D (inclusive) in each eye.
- •For Phase II, the best corrected, monocular, distance visual acuity must be 20/25 or better in each eye.
排除标准
- •Potential subjects who meet any of the following criteria will be excluded from participating in the study:
- •Be currently pregnant or lactating.
- •Be currently using any ocular medications or have any ocular infection of any type.
- •By self-report, have any ocular or systemic disease, allergies, infection, or use of medication that might contraindicate or interfere with contact lens wear, or otherwise compromise study endpoints, including infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive disease (e.g., Human Immunodeficiency Virus [HIV]), autoimmune disease (e.g. rheumatoid arthritis, Sjögren's syndrome), or history of serious mental illness or seizures.
- •Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (e.g. SynergEyes, SoftPerm) within the past 6 months.
- •Be currently wearing monovision or multifocal contact lenses.
- •Be currently wearing lenses in an extended wear modality.
- •Have participated in a contact lens or lens care product clinical trial within 30 days prior to study enrollment.
- •Be an employee (e.g., Investigator, Coordinator, Technician) or immediate family member of an employee (including partner, child, parent, grandparent, grandchild or sibling of the employee or their spouse) of the clinical site.
- •Have clinically significant (grade 3 or higher on the FDA grading scale) slit lamp findings (e.g., corneal edema, neovascularization or staining, tarsal abnormalities or bulbar injection) or other corneal or ocular disease or abnormalities that contraindicate contact lens wear or may otherwise compromise study endpoints (including entropion, ectropion, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, moderate or above corneal distortion, herpetic keratitis).
- •Have a history of strabismus or amblyopia.
- •Have fluctuations in vision due to clinically significant dry eye or other ocular conditions.
- •Have had any ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, iridotomy, retinal laser photocoagulation, etc.).
- •Have signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar).
- •Have a history of eyelid injury, surgery or procedure that resulted in abnormal eyelid position or movement.
结局指标
主要结局
Mesopic Contrast Sensitivity at 6 Cpd
时间窗: Post screening up to 1 hour during Phase 1
Mesopic (\~3 cd/m2) contrast sensitivity at 6 cpd was measured on the right eye only with and without a broadband glare source (with glare followed after without glare). Testing included 8 reversals with the last 4 being averaged to provide the contrast threshold. If the reduction (indicating worse contrast sensitivity) in the estimated mean due to the glare source was about 0.1 log units, then it can be concluded that the glare light source was effective and the study can move to Phase 2.
Photopic Contrast Sensitivity at 6 Cpd
时间窗: Post screening up to 1 hour during Phase 1
Photopic (\~120 cd/m2) contrast sensitivity at 6 cpd was measured on the right eye only with and without a broadband glare source (with glare followed after without glare). Testing included 8 reversals with the last 4 being averaged to provide the contrast threshold. If the reduction (indicating worse contrast sensitivity) in the estimated mean due to the glare source was about 0.1 log units, then it can be concluded that the glare light source was effective and the study can move to Phase 2.
Photopic Resolution Acuity Using Landolt C's With a Glare Source
时间窗: At least 5 minutes post lens fitting up to 2 hours during Phase 2
Photopic resolution acuity using Landolt C's was measured separately for the right (OD) and left (OS) eyes, using an arcminute scale under bright light conditions (\~120 cd/m2) with a broadband glare source. The photopic resolution acuity on arcminute scale was converted to logMAR scale for the analysis purpose using a log transformation. Lower values indicate better acuity.
次要结局
- Photopic Contrast Sensitivity With a Glare Source(At least 5 minutes post lens fitting up to 2 hours during Phase 2)
- Mesopic Contrast Sensitivity With a Glare Source(At least 5 minutes post lens fitting up to 2 hours during Phase 2)